Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 28562-28563 [2023-09401]
Download as PDF
<![CDATA[
28562
Federal Register / Vol. 88, No. 86 / Thursday, May 4, 2023 / Notices
(identifying the transgenic mutation
assay as appropriate for followup for
any positive bacterial mutagenicity test
as opposed to other tests, which are
recommended under more limited
circumstances). When such in vivo
testing is warranted, industry
collaboration on the testing to develop
robust data and share results among
themselves could enhance scientific
analyses and could facilitate regulatory
decision-making. Similarly, we have
encouraged applicants to publish
scientific research and test results to
further scientific knowledge on NDSRIs
and facilitate regulatory decisionmaking, as appropriate.
II. Issues for Consideration and Request
for Comments
FDA is requesting comments from the
public regarding the identification,
assessment, and control of NDSRIs in
drug product development and
regulatory review to provide interested
parties an opportunity to comment on
scientific and regulatory considerations,
including areas that may benefit from
collaborative efforts. FDA is also
interested in any challenges preventing
industry from identifying, assessing,
and controlling NDSRIs that may assist
FDA in its analysis.
The questions posed below are not
meant to be exhaustive. FDA is
interested in other pertinent information
that stakeholders would like to provide
on issues and challenges related to
addressing NDSRIs. FDA is particularly
interested in comments on the following
topics:
ddrumheller on DSK120RN23PROD with NOTICES1
A. General Questions
1. What additional topics related to
the evaluation of nitrosamines should
be a priority for the Agency to address
through guidance documents?
2. What factors should FDA consider
in prioritizing its evaluation of NDSRIs
on a compound-specific basis?
3. What additional mitigation
strategies should be considered for
reducing NDSRI formation or
eliminating these impurities (where
feasible)?
B. NDSRI Risk Assessment
1. What scientific and technical
factors should FDA consider in
developing best practices for conducting
testing for NDSRIs (e.g., Ames test,
enhanced Ames test, followup in vitro
mutagenicity, in vivo transgenic gene
mutation test) in support of establishing
AI limits?
a. Are there other tests recommended
for assessing mutagenic potential of
NDSRIs, and how supportable are these
methods?
VerDate Sep<11>2014
17:12 May 03, 2023
Jkt 259001
b. Would ‘‘short-term’’
carcinogenicity testing (e.g., 6-month
transgenic mouse model) be informative
to evaluate the risk associated with
NDSRIs?
c. If so, what are the advantages and
disadvantages to such testing?
d. Are there other types of studies that
may further inform FDA about the risk
associated with NDSRI (e.g., in vitro/in
vivo metabolism, DNA biomarkers,
identification of reactive intermediates)?
2. FDA recommended in the
Nitrosamine Guidance that confirmatory
testing of drug products and submission
of required changes in drug applications
be concluded on or before October 1,
2023 (see Ref. 3 at 17). Would an
extension of the recommended timeline
for submission of changes in drug
applications as described in the
guidance to June 1, 2024, allow for
additional assessment of NDSRIs and
enable collaborative efforts among
affected applicants? How can FDA
further support manufacturers’ efforts
toward completion of confirmatory
testing?
C. Collaborative Efforts To Develop
NDSRI Data and Establish and
Implement Recommended AI Limits
1. How can FDA facilitate
collaborative efforts to generate reliable
compound-specific data on NDSRIs and
reduce the need for additional and
potentially duplicative testing?
2. Are there obstacles that industry
has encountered when engaging in
collaborative efforts that could allow
companies to share data to assess the
safety of NDSRIs, particularly with the
intent of reducing redundant testing and
integrating the 3R principles? Such
examples of collaboration may include
enhancing (Q)SAR methods and models,
conducting in vitro mutagenicity testing
and/or in vivo transgenic gene mutation
tests. If there are such obstacles, are
there ways that FDA could facilitate
collaboration?
D. Establishing and Implementing
Recommended AI Limits and Access to
Medications
1. In implementing recommendations
for controlling nitrosamines, including
NDSRIs, have manufacturers or
suppliers experienced difficulties with
meeting recommended AI limits that
has led to discontinuation of
manufacturing or distribution?
III. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
PO 00000
Frm 00104
Fmt 4703
Sfmt 4703
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. Food and Drug Administration (FDA)
guidance for industry ‘‘ANDAs: Impurities in
Drug Substances,’’ June 2009, available at
https://www.regulations.gov/document/FDA1998-D-0021-0008.
2. FDA guidance for industry ‘‘ANDAs:
Impurities in Drug Products,’’ November
2010, available at https://www.fda.gov/
media/71351/download.
3. FDA guidance for industry ‘‘Control of
Nitrosamine Impurities in Human Drugs,’’
February 2021, available at https://
www.fda.gov/media/141720/download.
4. FDA, ‘‘Updates on Possible Mitigation
Strategies To Reduce the Risk of Nitrosamine
Drug Substance-Related Impurities in Drug
Products,’’ available at https://www.fda.gov/
drugs/drug-safety-and-availability/updatespossible-mitigation-strategies-reduce-risknitrosamine-drug-substance-relatedimpurities. Last accessed April 14, 2023.
5. FDA and International Council for
Harmonisation guidance for industry
‘‘M7(R1) Assessment and Control of DNA
Reactive (Mutagenic) Impurities in
Pharmaceuticals To Limit Potential
Carcinogenic Risk,’’ March 2018, available at
https://www.fda.gov/media/85885/download.
6. FDA and International Council for
Harmonisation guidance for industry,
‘‘M3(R2) Nonclinical Safety Studies for the
Conduct of Human Clinical Trials and
Marketing Authorization for
Pharmaceuticals’’ January 2010, available at
https://www.fda.gov/media/71542/download.
Dated: May 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09526 Filed 5–3–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2022–N–1894; FDA–
2018–N–3303; FDA–2022–N–0576; FDA–
2022–N–1794; FDA–2011–N–0902; FDA–
2009–N–0545; FDA–2016–N–2474; FDA–
2010–D–0350; FDA–2012–D–0530; FDA–
2016–N–2683; FDA–2013–N–0403; FDA–
2013–N–0134; FDA–2022–N–2440; FDA–
2013–N–0879; and FDA–2014–N–1048]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
SUMMARY:
E:\FR\FM\04MYN1.SGM
04MYN1
28563
Federal Register / Vol. 88, No. 86 / Thursday, May 4, 2023 / Notices
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
SUPPLEMENTARY INFORMATION:
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey ....
Electronic Products Requirements ..........................................................................................................................
Investigational Device Exemptions ..........................................................................................................................
General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions ........................................
Prescription Drug Product Labeling; Medication Guide Requirements ...................................................................
Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product
Deviations in Manufacturing .................................................................................................................................
Designation of New Animal Drugs for Minor Use or Minor Species .......................................................................
Tobacco Retailer Training Programs .......................................................................................................................
Q-Submission and Early Payor Feedback Request Programs for Medical Devices ..............................................
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration ......................
Protection of Human Subjects and Institutional Review Boards .............................................................................
Mammography Standards Quality Act Requirements .............................................................................................
Biologics License Applications; Procedures & Requirements .................................................................................
Procedures for the Safe Processing and Importing of Fish and Fishery Products ................................................
Medical Device Labeling Regulations; Unique Device Identification ......................................................................
Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09401 Filed 5–3–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1553]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Vaccines and Related
Biological Products Advisory
Committee (VRBPAC). The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. On June 15, 2023, the
committee will meet in open session to
discuss and make recommendations on
the selection of strain(s) to be included
in the periodic updated COVID–19
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:12 May 03, 2023
Jkt 259001
vaccines for the 2023–2024 vaccination
campaign. The meeting will be open to
the public. FDA is establishing a docket
for public comment on this document.
DATES: The meeting will be held
virtually on June 15, 2023, from 8:30
a.m. to 5 p.m. Eastern Time.
ADDRESSES: Please note that all meeting
participants will be joining this advisory
committee meeting via an online
teleconferencing platform. The online
web conference meeting will be
available at the following link on the
day of the meeting: https://
youtube.com/live/gBOyPREXGh8.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–1553.
The docket will close on June 14, 2023.
Either electronic or written comments
on this public meeting must be
submitted by June 14, 2023. Please note
that late, untimely filed comments will
not be considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 14, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
Comments received on or before June
7, 2023, will be provided to the
committee. Comments received after
PO 00000
Frm 00105
Fmt 4703
Sfmt 4703
Date
approval
expires
0910–0912
0910–0025
0910–0078
0910–0340
0910–0393
3/31/2024
2/28/2026
2/28/2026
2/28/2026
2/28/2026
0910–0458
0910–0605
0910–0745
0910–0756
0910–0847
0910–0130
0910–0309
0910–0338
0910–0354
0910–0485
2/28/2026
2/28/2026
2/28/2026
2/28/2026
2/28/2026
3/31/2026
3/31/2026
3/31/2026
3/31/2026
3/31/2026
June 7, 2023, and by June 14, 2023, will
be taken into consideration by FDA. In
the event that the meeting is canceled,
FDA will continue to evaluate any
relevant applications or information,
and consider any comments submitted
to the docket, as appropriate. You may
submit comments as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
E:\FR\FM\04MYN1.SGM
04MYN1
]]>Agencies
[Federal Register Volume 88, Number 86 (Thursday, May 4, 2023)]
[Notices]
[Pages 28562-28563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09401]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2022-N-1894; FDA-2018-N-3303; FDA-2022-N-0576; FDA-
2022-N-1794; FDA-2011-N-0902; FDA-2009-N-0545; FDA-2016-N-2474; FDA-
2010-D-0350; FDA-2012-D-0530; FDA-2016-N-2683; FDA-2013-N-0403; FDA-
2013-N-0134; FDA-2022-N-2440; FDA-2013-N-0879; and FDA-2014-N-1048]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a
[[Page 28563]]
list of information collections that have been approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Yale-Mayo Clinic Centers of Excellence 0910-0912 3/31/2024
in Regulatory Science and Innovation
B12 Pediatric Device Survey............
Electronic Products Requirements........ 0910-0025 2/28/2026
Investigational Device Exemptions....... 0910-0078 2/28/2026
General Drug Labeling Provisions and OTC 0910-0340 2/28/2026
Monograph Drug User Fee Submissions....
Prescription Drug Product Labeling; 0910-0393 2/28/2026
Medication Guide Requirements..........
Reporting of Biological Product 0910-0458 2/28/2026
Deviations and Human Cells, Tissues,
and Cellular and Tissue-Based Product
Deviations in Manufacturing............
Designation of New Animal Drugs for 0910-0605 2/28/2026
Minor Use or Minor Species.............
Tobacco Retailer Training Programs...... 0910-0745 2/28/2026
Q-Submission and Early Payor Feedback 0910-0756 2/28/2026
Request Programs for Medical Devices...
Data To Support Social and Behavioral 0910-0847 2/28/2026
Research as Used by the Food and Drug
Administration.........................
Protection of Human Subjects and 0910-0130 3/31/2026
Institutional Review Boards............
Mammography Standards Quality Act 0910-0309 3/31/2026
Requirements...........................
Biologics License Applications; 0910-0338 3/31/2026
Procedures & Requirements..............
Procedures for the Safe Processing and 0910-0354 3/31/2026
Importing of Fish and Fishery Products.
Medical Device Labeling Regulations; 0910-0485 3/31/2026
Unique Device Identification...........
------------------------------------------------------------------------
Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09401 Filed 5-3-23; 8:45 am]
BILLING CODE 4164-01-P
